First-Time Generic Approvals: AccuNeb, Coreg, Famvir

Jill Taylor

September 28, 2007

September 28, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for albuterol sulfate inhalation solution in the 0.021% (base) strength for relief of bronchospasm; carvedilol 3.125-, 6.25-, 12.5-, and 25-mg tablets for certain cardiovascular conditions; and famciclovir 125-, 250-, and 500-mg tablets for acute herpes zoster.

Generic Albuterol Sulfate Inhalation Solution ( AccuNeb) for Relief of Bronchospasm

On September 25, the FDA approved the first generic formulation of albuterol sulfate inhalation solution (generic, Watson Pharmaceuticals, Inc; comparable brand, AccuNeb, Dey, LP) in the 0.021% (base) strength for relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

Asthma, a condition characterized by inflammation of the passages through which air travels to the lungs, affects an estimated 20 million Americans and is the most common chronic condition among children. The symptoms, including breathing difficulty, tightness in the chest, wheezing, and coughing, can become severe enough to cause death.

Albuterol sulfate is a beta-adrenergic agonist that has been shown to relax the tightening and swelling of muscles around the airways (bronchospasm) for up to 6 hours in children.

Generic Carvedilol ( Coreg) for Cardiovascular Conditions

On September 5, the FDA approved the first generic formulations of carvedilol (generic, multiple manufacturers; comparable brand, Coreg, GlaxoSmithKline) 3.125-, 6.25-, 12.5-, and 25-mg tablets for the treatment of mild to severe chronic heart failure, left ventricular dysfunction following myocardial infarction in clinically stable patients, and hypertension.

Generic formulations of carvedilol were approved for the following companies: Actavis Elizabeth LLC, Apotex Inc, Aurobindo Pharma Limited, Caraco Pharmaceutical Laboratories Limited, Dr. Reddy's Laboratories, Glenmark Pharmaceuticals Limited, Lupin Limited, Mylan Pharmaceuticals Inc, Ranbaxy Laboratories Ltd, Sandoz Inc, Taro Pharmaceutical Industries Ltd, TEVA Pharmaceuticals USA, Watson Laboratories Inc, and Zydus Pharmaceuticals USA Inc.

Cardivedilol is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. The basis for the beneficial effects of the drug in the indicated conditions has not yet been established.

Generic Famciclovir ( Famvir) for Acute Herpes Zoster

On August 24, the FDA approved the first generic formulation of famciclovir (generic, Teva Pharmaceutical Industries, Ltd; comparable brand, Famvir, Novartis) 125-, 250-, and 500-mg tablets for the treatment of acute herpes zoster.

Herpes zoster, otherwise known as shingles, is a localized viral infection that results in a blistering rash. It is caused by varicella-zoster, the same virus that causes chickenpox. Outbreaks of the virus appear to be associated with aging, stress, or an impaired immune system and can be both painful and debilitating.

Famciclovir is a prodrug of penciclovir, an antiviral agent that can be used topically for the treatment of herpes simplex labialis (cold sores). In addition to the varicella-zoster virus, famciclovir has demonstrated inhibitory activity against herpes simplex virus types 1 and 2.


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